Sacral Neuromodulation in Pediatric Gastrointestinal Motility Disorders: An Exploratory Prospective Cohort Analysis of Clinical Outcomes Based on Different Approaches.

OBJECTIVES

To evaluate the efficacy and safety of minimally invasive sacral neuromodulation (SNM) and noninvasive enteral neuromodulation (ENM) in children with refractory gastrointestinal motility disorders (GMD).

MATERIALS AND

METHODS

This prospective exploratory trial enrolled pediatric patients with GMD between 2019 and 2024 at a single tertiary referral center. Children with inflammatory bowel disease or mechanical causes of GMD were excluded. Participants received either SNM through an implanted device or ENM through surface electrodes. Stimulation was delivered at 14 Hz, 210 μs pulse width, with individualized intensity (median 1.0 mA for SNM; 6.0 mA for ENM). Primary outcomes were abdominal pain, fecal incontinence, defecation frequency, and stool consistency. Treatment success was defined as clinically significant improvement in at least two of these four domains. Quality of life was assessed at baseline and 12 weeks. Safety outcomes were monitored over a 12-month follow-up.

RESULTS

Of 70 eligible patients, 48 completed the study (18 SNM; 30 ENM). Diagnoses included Hirschsprung disease, functional constipation, and congenital neuronal malformations. Severe comorbidities were more frequent in the SNM group (45%) than the ENM group (3%; p = 0.0018). Treatment success was observed in 80% (24/30) of the ENM cohort and 83% (15/18) of SNM cohort. No significant differences were found between groups for individual outcomes. No major complications occurred. Minor adverse events were comparable (ENM 27%; SNM 17%).

CONCLUSIONS

Both SNM and ENM are effective and safe options for treating pediatric GMD and may be considered within a multimodal therapeutic approach.

CLINICAL TRIAL REGISTRATION: This trial is registered at clinicaltrials.gov (ID NCT04713085, title "Sacral Neuromodulation in Children and Adolescents"). Web link: https://clinicaltrials.gov/study/NCT04713085.